Experienced CRA, Sponsor Dedicated - Italy

Overview

In this role you support multicenter clinical studies by monitoring site conduct, data integrity, and regulatory compliance to ensure study success. You collaborate with sites to recruit participants, train staff, and manage issues, while coordinating with the study team for timely execution. You will contribute to quality oversight, document management, and study milestones, helping to advance patient outcomes and scientific rigor. This position offers exposure to global trials and cross-functional collaboration.

Responsabilità

• Perform site monitoring visits (selection, initiation, monitoring, close-out) per scope of work and GCP
• Drive and track subject recruitment plans aligned with project needs
• Administer protocol training and maintain regular site communication
• Assess site practices for protocol adherence and regulatory compliance; escalate issues
• Manage study progress: regulatory submissions, recruitment, CRF completion, data queries
• Ensure TMF/ISF documentation is complete and compliant
• Create and maintain monitoring documentation, visit reports, and follow-up letters
• Collaborate with study team for project execution support
• Support site-specific recruitment planning and, if applicable, site financial management and invoicing

Requisiti fondamentali

• Bachelor's and Master's Degree in scientific discipline or health care
• At least 3 years of on-site monitoring experience
• CRA Certification according to Ministerial Decree dated 15.11.2011
• Knowledge of GCP and ICH guidelines
• Therapeutic and protocol knowledge provided by company training
• Proficiency with Microsoft Word, Excel and PowerPoint; use of laptop, iPhone and iPad where applicable
• Strong written and verbal English communication
• Organizational and problem-solving skills
• Time and financial management skills
• Ability to build effective working relationships
• Organizational skills
• Problem-solving
• Effective communication
• GCP and ICH regulatory knowledge
• Clinical trial documentation and TMF management
• CRF completion and data query handling